Sonoran Vein And Endovascular

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on lack of established policies, review of patient test records for specimens tested on the i-Stat analyzer and interview with the technical consultant (TC-1), (A) the laboratory failed to establish written policies and procedures to ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results; and (B) the laboratory failed to positively identify one out of four patient specimens tested by the laboratory. Findings include: 1. The laboratory began patient testing in August 2023 on the i-Stat analyzer and reports 105 tests annually in the specialties of Chemistry and Hematology. A2. The laboratory failed to provide evidence of an established written policy and procedure to ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results for Chem8+ and PT/INR testing. A3. The TC-1 interviewed on 6/18/25 at 12: 07 PM confirmed the laboratory failed to provide evidence of written policies and procedures to ensure positive identification and optimum integrity of a patient's specimen throughout the entire testing process, for testing performed on the i-Stat analyzer. B1. The TC-1 interviewed on 6/18/25 at 11:50 AM stated that the testing personnel manually enter the patient's birth date into the i-Stat analyzer as the unique patient identifier prior to testing the sample. The patient identifier is included on the i- Stat instrument printout. B2. One out of four patient test records reviewed during the survey failed to include a unique specimen identification number. Review of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- instrument printout for Chem8+ test results from 8/26/24 indicated the testing personnel manually entered the patient ID into the analyzer as '333'. B3. The TC-1 interviewed on 6/18/15 at 11:50 AM confirmed the laboratory failed to positively identify the specimen throughout the entire test process for the patient indicated above. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of established Quality Assessment (QA) policies, review of Proficiency Testing (PT) records from 2023, 2024 and 2025 and interview with the Technical Consultant (TC-1) on June 18, 2025, the laboratory failed to establish policies and procedures for the enrollment and performance of PT samples. Findings include: 1. The laboratory began patient testing in August 2023 in the subspecialties of Routine Chemistry and Hematology with a reported annual test volume of 105. 2. No evidence was provided for review to indicate the laboratory established policies and procedures specific to the enrollment and performance of proficiency testing, including but not limited to, enrollment, testing of the PT samples, PT referral, review of graded PT results and

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) reports from 2023 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Protime. Findings include: 1. The laboratory's PT performance was unsatisfactory for the second event of 2023 for the regulated analyte, Protime, with a score of 60%. 2. The laboratory's PT performance was unsatisfactory for the third event of 2023 for the regulated analyte, Protime, with a score of 60%. 3. Unsatisfactory participation in the second and third events of 2023 (two consecuive testing events) for the regulated analyte, Protime, constitutes an initial unsuccessful PT performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the second and third events of 2023 for the regulated analyte, Protime. See D2016 for findings. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the second and third events of 2023 for the regulated anyalyte, Protime, resulting in unsuccessful performance. See D2016 for findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, Protime, for the second and third events of 2023. See D6000 for findings. -- 3 of 3 --